Identity
- Trade Name
- ExamVision Loupe System Kepler Reflekt 6.0x EUDAMED
- Device Name
- ExamVision Loupe System EUDAMED
- Model / Reference
- KR60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05744000230344 EUDAMED
- Basic UDI-DI
- 574400023EVLoupeXD EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ExamVision Loupe System Kepler Reflekt 6.0x by ExamVision A/S — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 574400023EVLoupeXD | Class I | Active |
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Manufacturer
- Manufacturer
- ExamVision A/S
- EUDAMED SRN
- DK-MF-000032397
Sources (1)
- EUDAMED 1baab077-b407-4532-857a-bb1f5ce8bd25 61 fields · synced Jul 22, 2026